Diagnostic Accuracy of Near Infrared Transillumination in Combination With a Dye in the Cavitation Detection

NCT04748913 | Unknown DMC

• 1 other identifier: Universidad Rey Juan Carlos
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study will be to make a comparison in vivo of the following techniques: DIAGNOcam, DIAGNOcam in combination with indocyanine and bitewing radiography, analyzing the ability to detect cavitation in initial proximal caries in posterior teeth using visual separation with tactile exploration as a gold standard. Methodology: During a period of 2 years, patients with initial proximal caries will be evaluated in the facilities of the clinic belonging to the Fundación de la Clínica Universitaria of the Rey Juan Carlos University (Madrid, Spain). Those subjects where a minimum of a proximal carious lesion (E1, E2 or D1) is diagnosed in posterior teeth will be candidates for the study. The exploration of proximal caries will be carried out in four phases: radiographic exploration, exploration with DIAGNOcam, exploration with DIAGNOcam and Indocyanine and visual-tactile exploration with separation. Once the visual-tactile examination with separation has been completed, the caries lesions will be treated. Depending on whether the lesion is cavitated or not, a non-invasive procedure or an operative treatment will be chosen.

Conditions

Initial Proximal Caries

Outcome Measures

Primary Outcomes (1)

• Near infrared transillumination

  Ability to detect cavitation in initial proximal caries of DIAGNOcam in combination with indocyanine

  2 years

Study Arms (2)

No intervention

NO INTERVENTION

Remineralization

OTHER

Device: Radiographic examination; Device: Scanning with DIAGNOcam; Device: Scan with DIAGNOcam and Indocyanine; Diagnostic Test: Visual-tactile exploration with separation

Interventions

Radiographic examination DEVICE

Standardized bitewing radiographs will be performed by the principal investigator

Remineralization

Scanning with DIAGNOcam DEVICE

The surface of the selected teeth will be examined under near infrared light using the DIAGNOcam device

Remineralization

Scan with DIAGNOcam and Indocyanine DEVICE

One the dye has been applied, a new series of images will be taken with Diagnocam

Remineralization

Visual-tactile exploration with separation DIAGNOSTIC_TEST

The point of contact will be open in the corresponding proximal area of the lesion using an elastic orthodontic separator

Remineralization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• E1, E2 and D1 proximal carious lesions in permanent posterior teeth (E1: outer half of enamel; E2: inner half of enamel; D1: outer half of dentin)

You may not qualify if:

• estructural abnormalities
• visible clinical cavitation
• restorations on the proximal surfaces
• open contact points
• overlapping structures on the X-ray that prevent a clear view of the proximal area

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Santiago De Vega Calleja

Alcorcón, Madrid, 28922, Spain

RECRUITING

MeSH Terms

Interventions

Diagnostic Imaging; Radionuclide Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 10, 2021
• Study Start: November 9, 2020
• Primary Completion: November 9, 2022
• Study Completion: November 9, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

ES (1)